First Trimester AbortionNCT05360186
New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
A study testing MateRegen® gel (BioRegen) in people with First Trimester Abortion and Surgical Abortion, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- First Trimester Abortion, Surgical Abortion, Miscarriage With Afibrinogenemia
- What is being tested?
- MateRegen® gel (BioRegen)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Jun 2022to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18 years old or above
- No previous history of IUA/ Asherman's syndrome
- No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
- No previous history of therapeutic hysteroscopic surgeries
- Voluntary informed consent and understanding of study
Who cannot join
- previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
- suspicion of molar pregnancy
- genital tract malformation
- suspicion of active infection or genital tract malignancy or genital tuberculosis
- abnormal blood coagulation
- inability to tolerate pelvic examination known
- suspected intolerance of hypersensitivity to NCH gel or its derivatives
- patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
PUI WAH JACQUELINE CHUNG, MBBS, +852 35051537, jacquelinechung@cuhk.edu.hk
Stacey Wong, Bsc, +852-35051764, staceywong@cuhk.edu.hk
About this study
Official title: The Efficacy and Safety of a New Cross-linked Hyaluronan Gel to Prevent Adhesion After Ultrasound-guided Manual Vacuum Aspiration (USG-MVA): A Prospective Randomized Controlled Trial
The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage.
- To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients.
- To examine the rate of complications or side effects with the NCH gel.
- To assess the subsequent menstrual history and reproductive outcome in both groups of patients.
Read the detailed description
There is limited data to evaluate the incidence of IUA after using this NCH gel in patients undergoing surgical evacuation via USG-MVA for the treatment of first-trimester miscarriage. Previous RCT showed a significant reduction in IUA with the use of NCH gel, with IUA detected in only 9.5% of patients with NCH gel applied compared to 24.1% in the control group. However, the group did not involve patients undergoing surgical evacuation by USG-MVA.
Therefore, the objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment of first-trimester miscarriage.
- Being tested
- MateRegen® gel (BioRegen)
- Keywords
- First Trimester Abortion, Surgical Abortion, Intrauterine adhesion, Hyaluronan gel, Protective Agents, Hyaluronic Acid, Manual vacuum aspiration, Miscarriage
- Medical subject headings
- Gynatresia, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MateRegen® gel (BioRegen)Device
Modification of Hyaluronic acid structure to 3-dimensional self-cross-linked network structure enables all-dimensional coverage of tissue surface to enhance better healing process. Self-cross-linked HA hydrogels can maintain the biocompatibility and biodegradability that characterize the unmodified material. Moreover, high dynamic viscosity enables continuous indwelling in the uterine cavity. The gel could provide precise regulation, and degradation and absorption time prolonged to 7-14 days post operatively, which completely cover key postoperative healing period (5-7 days), at the highest time of intrauterine adhesion formation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Group A): NCH gel after USG-MVA | Experimental | In the intervention group (Group A), a 15 cm sterile delivery cannula will be inserted through the internal os and a syringe of NCH gel (5ml) will be applied to the uterine cavity after cleansing the cervix with an antiseptic solution. Receives: Device: MateRegen® gel (BioRegen) |
| Controlled group (Group B): No NCH gel after USG-MVA | No intervention | In the control group (Group B), as the patient is conscious during the procedure, an empty 5ml syringe will be inserted into the internal os and held for 1 minute as a sham procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IUA
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.
Measured: 8-12 weeks after MVA
Secondary outcomes (5)
Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
To study the severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score in both groups of patients.
The American Fertility Society's (AFS) classification of intrauterine adhesions:
Stage I (mild) with score 1-4, Stage II (moderate) with score 5-8, Stage III (severe) with score 9-12
Measured: 8-12 weeks after MVA
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
To study the severity and extent of the intrauterine adhesions as assessed by the European Society of Gynaecological Endoscopy (ESGE) adhesion score in both groups of patients. It includes grades I and II as mild adhesion, grade III as moderate adhesion, grades IV and V as severe adhesion
Measured: 8-12 weeks after MVA
Complications or side effects with the NCH gel.
To examine the rate of complications or side effects with the NCH gel.
Measured: 8-12 weeks after MVA
Subsequent menstrual frequency
To assess the subsequent menstrual frequency in both groups of patients. Frequency - average 28 days <24 days Frequent, >38 days Infrequent Frequency - average 28 days <24 days Frequent, >38 days Infrequent
Measured: 8-12 weeks after MVA
Subsequent reproductive outcome
To assess the rate of pregnancy in both groups of patients
Measured: 8-12 weeks after MVA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start14 Jun 2022
- Primary completion14 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Trimester AbortionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360186
- Sponsor's protocol ID
- 2021.702-T
- Status last verified
- Aug 2025
- First submitted
- 31 Mar 2022
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a New Cross-linked Hyaluronan Gel to Prevent Adhesion After Ultrasound-guided Manual Vacuum Aspiration (USG-MVA): A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05360186
- Acronym / sponsor ID
- 2021.702-T
- Keywords
- First Trimester Abortion, Surgical Abortion, Intrauterine adhesion, Hyaluronan gel, Protective Agents, Hyaluronic Acid, Manual vacuum aspiration, Miscarriage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment for first-trimester miscarriage.
- To study the severity and extent of the IUA as assessed by the AFS and ESGE adhesion score in both groups of patients.
- To examine the rate of complications or side effects with the NCH gel.
- To assess the subsequent menstrual history and reproductive outcome in both groups of patients.
Detailed description
There is limited data to evaluate the incidence of IUA after using this NCH gel in patients undergoing surgical evacuation via USG-MVA for the treatment of first-trimester miscarriage. Previous RCT showed a significant reduction in IUA with the use of NCH gel, with IUA detected in only 9.5% of patients with NCH gel applied compared to 24.1% in the control group. However, the group did not involve patients undergoing surgical evacuation by USG-MVA.
Therefore, the objective of this prospective, randomized controlled study was to evaluate the effectiveness of this NCH gel in the prevention of IUA development as assessed by hysteroscopy after USG-MVA, in the treatment of first-trimester miscarriage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Group A): NCH gel after USG-MVA | Experimental | Device: MateRegen® gel (BioRegen)In the intervention group (Group A), a 15 cm sterile delivery cannula will be inserted through the internal os and a syringe of NCH gel (5ml) will be applied to the uterine cavity after cleansing the cervix with an antiseptic solution. |
| Controlled group (Group B): No NCH gel after USG-MVA | No intervention | –In the control group (Group B), as the patient is conscious during the procedure, an empty 5ml syringe will be inserted into the internal os and held for 1 minute as a sham procedure. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women 18 years old or above
- No previous history of IUA/ Asherman's syndrome
- No previous surgical history of EVA or dilatation or curettage or surgical termination of pregnancy or caesarean section
- No previous history of therapeutic hysteroscopic surgeries
- Voluntary informed consent and understanding of study
Key exclusion criteria (8 listed)
- previous therapeutic hysteroscopic procedures (e.g. endometrial ablation, removal of fibroids or polyps, surgical correction of congenital uterine anomalies or adhesiolysis)
- suspicion of molar pregnancy
- genital tract malformation
- suspicion of active infection or genital tract malignancy or genital tuberculosis
- abnormal blood coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MateRegen® gel (BioRegen)Modification of Hyaluronic acid structure to 3-dimensional self-cross-linked network structure enables all-dimensional coverage of tissue surface to enhance better healing process. Self-cross-linked HA hydrogels can maintain the biocompatibility and biodegradability that characterize the unmodified material. Moreover, high dynamic viscosity enables continuous indwelling in the uterine cavity. The gel could provide precise regulation, and degradation and absorption time prolonged to 7-14 days post operatively, which completely cover key postoperative healing period (5-7 days), at the highest time of intrauterine adhesion formation. | Device | Intervention group (Group A): NCH gel after USG-MVA |
Primary outcome
Incidence of IUA
Time frame: 8-12 weeks after MVA
To determine the incidence of IUA or after USG-MVA for the treatment of first-trimester miscarriage in both intervention and control groups.
5 secondary outcomes
Severity and extent of the intrauterine adhesions as assessed by the AFS adhesion score
Time frame: 8-12 weeks after MVA
Severity and extent of the intrauterine adhesions as assessed by the ESGE adhesion score
Time frame: 8-12 weeks after MVA
Complications or side effects with the NCH gel.
Time frame: 8-12 weeks after MVA
Subsequent menstrual frequency
Time frame: 8-12 weeks after MVA
Subsequent reproductive outcome
Time frame: 8-12 weeks after MVA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MateRegen® gel (BioRegen) in people with First Trimester Abortion and Surgical Abortion, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaine NG (35052745, elaineng@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of IUA (time frame: 8-12 weeks after MVA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.